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Infusion Pumps Total Product Life Cycle Infusion Pumps Total Product Life Cycle Guidance for Industry and FDA Staff Document issued on: December 2, 2014. The draft of this document was issued on April 23, 2010. This document supersedes the “Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps,” issued March, 1993. For questions regarding this document, please contact Alan Stevens, General Hospital Devices Branch, Office of Device Evaluation at 301-796-6294 or via email at [email protected]. For questions regarding safety assurance cases, please contact Richard Chapman, General Hospital Devices Branch, Office of Device Evaluation at 301-796-2585 or via email at [email protected]. For questions regarding pre-clearance inspections, please contact Francisco Vicenty, Respiratory, Ear/Nose/Throat, General Hospital, Infectious Control, and Ophthalmic Devices Branch, Office of Compliance at 301-796-5770 or via email at [email protected]. For questions pertaining to manufacturer reporting requirements, please contact Sharon Kapsch at 301-796-6104 or via email at [email protected]. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices General Hospital Devices Branch Contains Nonbinding Recommendations Preface Public Comment You may submit electronic comments and suggestions at any time for Agency consideration to http://www.regulations.gov. Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Identify all comments with the docket number FDA-2010-D-0194. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet. You may also send an e-mail request to CDRH- [email protected] to receive a copy of the guidance. Please use the document number 1694 to identify the guidance you are requesting. 2 Contains Nonbinding Recommendations Table of Contents 1. INTRODUCTION ............................................................................................................................................... 4 2. BACKGROUND .................................................................................................................................................. 5 3. SCOPE .................................................................................................................................................................. 5 4. DEVICE DESCRIPTION ................................................................................................................................... 6 5. SAFETY ASSURANCE CASE........................................................................................................................... 9 A. GENERAL CONSIDERATIONS FOR SAFETY CASE DEVELOPMENT............................................... 10 B. HAZARD ANALYSIS ...................................................................................................................................... 12 C. PERFORMANCE TESTING ........................................................................................................................... 17 D. LABELING ........................................................................................................................................................ 29 E. ALARMS ............................................................................................................................................................ 32 F. SAFETY CONTROL MECHANISMS............................................................................................................ 32 6. 510(K) PRE-CLEARANCE INSPECTION OF INFUSION PUMP MANUFACTURERS ....................... 33 7. POSTMARKET SURVEILLANCE OF INFUSION PUMPS ....................................................................... 34 3 Infusion Pumps Total Product Life Cycle Guidance for Industry and FDA Staff This guidance represents the Food and Drug Administration’s (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. 1. Introduction The Food and Drug Administration (FDA) has developed this guidance document to assist industry in preparing premarket submissions for infusion pumps and to identify device features that manufacturers should address throughout the total product life cycle. Infusion pumps, as described in 21 CFR 880.5725, are intended for use in a health care facility to pump fluids1 into a patient in a controlled manner.2 The recommendations in this guidance are intended to improve the quality of infusion pumps in order to reduce the number of recalls and adverse events associated with their use. The FDA believes that these recommendations will help mitigate current risk and reduce future risk associated with infusion pumps. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required. 1 For purposes of this guidance, the term “fluids” refers to FDA approved drugs and licensed biological products. 2 This guidance also includes recommendations for prescription infusion pumps intended for use by lay users in the home or elsewhere. For purposes of this guidance, “lay users” or “home users” are users who receive infusion pumps from or on the order of a health care provider and who use the pumps under the supervision of a licensed practitioner in any setting outside a healthcare facility, including the home. 4 2. Background The FDA has evaluated a broad spectrum of infusion pumps across manufacturers and has encountered problems with device software, human factors, reliability and manufacturing. Based on an evaluation of reported adverse events and recalls, FDA believes that many injuries and adverse events may be avoided by improving the design verification and validation processes for these devices. The most frequently reported infusion pump device problems are: software error messages, human factors (e.g., use error related to instructions for use, training, and other user interface issues), broken components, battery failure, alarm failure, and over infusion and under infusion. In some reports, the manufacturer was unable to determine or identify the problem and reported the problem as “unknown.” Subsequent analyses revealed that many of these were related to design problems that could be corrected during the design processes. This guidance is intended to improve the quality of infusion pumps and thereby reduce the incidence of these problems. 3. Scope The scope of this document is limited to class II devices classified under the regulation, 21 CFR 880.5725, which includes devices with the product codes listed in Table 1. The product codes listed are those that currently fall within the scope of 21 CFR 880.5725. Devices classified with future product codes created under 21 CFR 880.5725 following publication of this guidance are within the scope of this guidance document. Note that infusion pumps submitted as part of a class III system are subject to the premarket approval application (PMA) pathway. While this guidance may provide valuable information regarding the elements to consider for a pump submitted as part of a PMA, such as hazard identification and sources of hazardous situations, not all items addressed in this guidance and recommended for a 510(k) submission would be relevant to a PMA submission. In addition, additional items may be required for a PMA that would not be required as part of a 510(k) submission. § 880.5725 Infusion pump (a) Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm. (b) Classification. Class II (performance standards). Table 1 Product code Description FRN Infusion pump MEA Patient controlled analgesia (PCA) infusion pump MEB Elastomeric infusion pump LZG Insulin infusion pump OPP Insulin bolus infusion pump LZH Enteral infusion pump 5 MRZ Infusion pump accessories PHC Infusion Safety Management Software For purposes of this guidance document, FDA defines the infusion pump system to include the: • Infusion pump; • Fluid infusion set for the complete fluid pathway from, and including, the drug reservoir or fluid source container (e.g., bag, cassette,
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